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Collaborative Care for Depression and Diabetic Retinopathy in African Americans (CC-DDR)

Primary Purpose

Diabetic Retinopathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Activation
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Retinopathy focused on measuring Depression, Health disparities, African American, Geriatric

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. African-American race
  2. age ≥ 65 years
  3. type 2 diabetes
  4. mild or moderate nonproliferative DR with or without macular edema
  5. depressive symptoms (i.e., Patient Health Questionnaire-9 score ≥5)
  6. HbA1C ≥ 7.0%

Exclusion Criteria:

  1. treated proliferative DR
  2. global cognitive impairment (i.e., Mini Mental Status score ≤ 20)
  3. psychiatric diagnosis other than depression
  4. treatment for depression started in the previous 3 months
  5. life expectancy under 2 years

Sites / Locations

  • Thomas Jefferson University
  • Wills Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Behavioral Activation

Usual Care

Arm Description

CC-DDR is a novel mental health/ophthalmologic intervention that we are designing to treat depression and lower HbA1C levels in older AAs with mild-to-moderate DR and comorbid depression. Community Health Workers, who match participants in race and cultural background, will work with ophthalmologists in the retina clinic to educate participants on the links between depression, HbA1C, and DR, and will extend care into the home where they will use Behavioral Activation to treat depression and improve diabetes self-management skills.

Usual Care

Outcomes

Primary Outcome Measures

Hemoglobin A1c
Change in hemoglobin A1c from baseline to 12 months

Secondary Outcome Measures

Full Information

First Posted
April 21, 2014
Last Updated
February 20, 2019
Sponsor
Thomas Jefferson University
Collaborators
Wills Eye
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1. Study Identification

Unique Protocol Identification Number
NCT02121340
Brief Title
Collaborative Care for Depression and Diabetic Retinopathy in African Americans
Acronym
CC-DDR
Official Title
Collaborative Care for Depression and Diabetic Retinopathy in African Americans
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University
Collaborators
Wills Eye

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In this feasibility/pilot study, we will develop, refine, and evaluate the feasibility of a novel mental health/ophthalmologic intervention called, "Collaborative Care for Depression and Diabetic Retinopathy" (CC-DDR), which aims to treat depression and lower HbA1C in older African Americans with mild-to-moderate diabetic retinopathy (DR) and comorbid depression.
Detailed Description
The Specific Aims are: To develop the CC-DDR treatment protocol. This will involve: Creating an initial version of the CC-DDR treatment protocol. Refining the protocol based on input from an expert panel with expertise in DR, depression, and culturally relevant interventions for diabetes in older African Americans. Developing a tool to assess interventionist treatment adherence and competence. To conduct an open trial of CC-DDR with 40 participants who have poorly controlled diabetes, depression, and mild or moderate DR. During this open trial we will: Evaluate the feasibility of CC-DDR. Refine the CC-DDR treatment protocol by incorporating feedback from participants, community health care workers (CHWs), ophthalmologists, and the expert panel. Refine procedures for recruitment and retention, outcome assessment, monitoring treatment fidelity, CHW training and supervision, quality assurance, and study administration, based on input from investigators, CHWs, participants, and the expert panel. Examine CC-DDR's impact on depression severity; diabetes self-management practices; HbA1C level; blood pressure; adherence to the ophthalmologist treatment plan; vision function; quality of life; and satisfaction with CC-DDR. To complete a Manual of Procedures that characterizes all aspects of the planned efficacy trial of CC-DDR.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
Keywords
Depression, Health disparities, African American, Geriatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Activation
Arm Type
Experimental
Arm Description
CC-DDR is a novel mental health/ophthalmologic intervention that we are designing to treat depression and lower HbA1C levels in older AAs with mild-to-moderate DR and comorbid depression. Community Health Workers, who match participants in race and cultural background, will work with ophthalmologists in the retina clinic to educate participants on the links between depression, HbA1C, and DR, and will extend care into the home where they will use Behavioral Activation to treat depression and improve diabetes self-management skills.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual Care
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Activation
Primary Outcome Measure Information:
Title
Hemoglobin A1c
Description
Change in hemoglobin A1c from baseline to 12 months
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Depression
Description
Improvement in depressive symptoms from baseline to 12 months
Time Frame
12 months
Title
Progression of diabetic retinopathy
Time Frame
Baseline to 12 months
Title
Diabetes self management
Description
Improvement from baseline to 12 months
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: African-American race age ≥ 65 years type 2 diabetes mild or moderate nonproliferative DR with or without macular edema depressive symptoms (i.e., Patient Health Questionnaire-9 score ≥5) HbA1C ≥ 7.0% Exclusion Criteria: treated proliferative DR global cognitive impairment (i.e., Mini Mental Status score ≤ 20) psychiatric diagnosis other than depression treatment for depression started in the previous 3 months life expectancy under 2 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry Rovner, MD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robin Casten, PhD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Study Director
Facility Information:
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Wills Eye Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

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Collaborative Care for Depression and Diabetic Retinopathy in African Americans

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